Senior Medical Advisor - Remote - With National Institute of Health

Location : Remote

Weekly Hours - PT: Less than 30 hours per week Total No. of Hours : 28

Overall Position Summary And Objectives

NCI is in need of a senior physician consultant to work as a Subject Matter Expert (SME) with NCI/CTEP within DCTD to provide guidance that shall be used by NCI leadership to inform their decision-making process. The consulting SME shall provide guidance on the background justification for the scientific objectives and medical safety of the trials supported by CTEP, the interaction between the regulatory aspects of clinical trial agreements and terms for trials with pharmaceutical collaborators and extramural investigators, and comment on the content and provide feedback on specific concerns by the extramural investigators.

Min Education - Master's

Resume Max Pages - 3

Certifications & Licenses

• M.D.
• Licensed physician or board eligible
  
  

Skills (Ranked By Priority)

• Extensive experience (minimum 10 years) in FDA regulatory requirements related to conduct of clinical treatment trials in oncology
• Extensive experience (minimum 10 years) in FDA regulatory requirements related to conduct of clinical treatment trials in oncology
• Senior-Level/Managerial leadership experience in academia, such as Chair of an academic or clinical department, or senior level position in the government
• Past participation in scientific advisory boards or committees, at least two (2).
• Active US License to practice medicine and board-certification in Medical Oncology
• Investigational New Drugs (IND)
  
  

Software

• Microsoft office
• SharePoint
• Outlook
  
  

Field of Study

• General Medical and Health Services
  
  

Statement of Work Details

Provides executive experience needed to conduct needs assessments and develop recommendations for improvements of current operations.

• Provide analyses, evaluations, technical assessments, feedback and support in the planning and implementation of activities.
• Collaborate with staff on program development, contract management, and Institute operations.
• Make recommendations on aspects of efficiency and continuous process improvement.
• Provide scientific and medical guidance to extramural DCTD/CTEP staff on selected hematologic and solid tumour malignancy clinical treatment trials and PMI trials being proposed and developed for conduct in the NCI National Clinical Trials Network (NCTN) 1
• Review clinical treatment trials, including Clinical Trials collaborations with pharmaceutical partners for trials involving
• cooperative research and development agreements (CRADAs) for which NCI/DCTD is the legal IND sponsor, in concordance with general CTEP policies and with policies specific for trials involving CTEP IND agents. 2
  
  

Collaborates with other professionals to develop recommendations for current and future initiatives.

• Provide advisory services and staff support to executives and senior managers on a full range of issues related to the support of all divisions and centres.
• Participate in appropriate meetings, in person or via phone/webinar and provide scientific and medical guidance related to selected hematologic and solid tumour trials and PMI trials. 3
• Provide scientific and medical guidance to pharmaceutical collaborators regarding appropriate scientific and medical rationale for language in the clinical agreements on selected hematologic and solid tumour malignancy treatment trials and PMI trials 4
  
  

Advises management and staff on formulation of new strategies and sensitive or complicated issues.

• Identify gaps in existing scientific knowledge and provide recommendations for future research efforts.
• Review administrative policies and procedures supporting NCI DCTD/CTEP PMIs and provide scientific and medical guidance to DCTD/CTEP to assist in their decision-making process. 5
  
  

Works with staff to develop and implement new and proactive programs geared to specific audiences.

• Provide scientific and medical insight related to the development of novel collaborations and treatment approaches for PMI trials as well as on other selected hematologic and solid tumour treatment trials with extramural investigators and pharmaceutical partners
• Provide professional scientific and medical opinion on future initiatives associated with special projects and precision medicine trials planning, as directed by DCTD. DCTD Leadership shall have final decision-making authority on all future initiatives.
  
  

Conducts research and analysis to proactively address and respond to inquiries on various policies and issues.

• Develop novel approaches on communicating the program to the public in a health care setting.
• Edit appropriate review assessments for both tissue agnostic and disease-specific trials, especially trials involving gastrointestinal malignancies. DCTD shall make all final decisions regarding assessments generated by the SME.
  
  

Coordinates and advances professional development and research done by others in areas where other mechanisms may not be optimal due to time constraints or other issues.

• Review scientific papers, reports and manuscripts prepared by others, prior to submission.